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Risk Evaluation and Mitigation Strategies (REMS): Staying Ahead of the Regulatory and Enforcement Landscape
Drugmakers’ latest Washington headache involves REMS. Changes are afoot inside the FDA and the halls of Congress, reaching all the way into the office of FDA Commissioner Gottlieb:
FDAnews has called on a Washington lawyer with a deep FDA regulatory background to show how these fast-moving changes could affect you. Katlin Backfield Esq., former Associate Chief Counsel for Drugs with the Office of Chief Counsel, walks you through:
Failure to prepare for REMS changes could result in penalties — civil, and even criminal ones. Don’t take that risk.
Katlin Backfield Esq., Attorney and Consultant, Backfield PLLC. In a 11-year FDA career, Ms. Backfield served as Associate Chief Counsel for Drugs with the Office of Chief Counsel and as regulatory counsel in the Office of Prescription Drug Promotion, CDER. Active in FDLI, she helped plan FDLI’s 2017 Advertising and Promotion Conference and serves on FDLI's Academic Programs Committee. She is based in Washington, D.C.
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